Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017714
Company: JUBILANT DRAXIMAGE

Products on NDA 017714

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AN-DTPA	TECHNETIUM TC-99M PENTETATE KIT	N/A	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017714

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/1976	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/12/2002	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
03/20/2002	SUPPL-21	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17714s21ltr.pdf
05/27/1997	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
02/23/1993	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
04/02/1986	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
01/27/1986	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
08/02/1985	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/29/1985	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
03/23/1984	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1983	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
06/30/1982	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
03/07/1979	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
03/07/1979	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
03/07/1979	SUPPL-1	Labeling		Label is not available on this site.